CompletedPhase 3

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Bulgaria, Czechia532 participantsStarted 2022-08-23

Plain-language summary

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.

Who can participate

Age range50 Years

SexFEMALE

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Exclusion criteria

✕. Evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism
✕. History and/or presence of 1 severe or more than 1 moderate vertebral fractures confirmed by x-ray.
✕. History of hip fracture
✕. Presence of active healing fractures
✕. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures
✕. Evidence of hypo/hypercalcemia at Screening
✕. Known vitamin D deficiency
✕. Known intolerance to calcium and vitamin D supplement.

What they're measuring

Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®.

Timeframe: Baseline to Month 12

To Demonstrate Comparable Profile of AVT03 and Prolia in Terms of Area Under the Percent Change From Baseline in Serum C-telopeptide of Type 1 Collagen (AUEC of %Cfb sCTX-1)

Timeframe: Baseline to Month 6

Trial details

NCT IDNCT05395091

SponsorAlvotech Swiss AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-07

Results submitted2025-04-23

View on ClinicalTrials.gov More Osteoporosis, Postmenopausal trials